Caudal Block vs Local Wound Infiltration for Hernia Repair in Children (CBvsLWI)

Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration

To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Bupivacain- Caudal; Procedure: Bupivacaine- Local

Detailed Description

Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI).

Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • Uctoariced

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 6 month to 7 years
• ASA physical status I or II
• undergoing unilateral hernia repair

Exclusion Criteria:

• history of developmental delay or mental retardation
• type I diabetes
• known or suspected coagulopathy
• known allergy to any local anesthetic
• known congenital anomaly of the spine
• signs of spinal anomaly or infection at the sacral or inguinal region

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacain -Caudal; Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%.	Procedure: Bupivacain- Caudal; Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).; Other Names: Caudal block
Active Comparator: Bupivacain- Local; Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%.	Procedure: Bupivacaine- Local; Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).; Other Names: Local Wound Infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Analgesic Requirement	The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total number of oral acetaminophen	Total number of analgesic requirement	The number of analgesic received for the period of 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Postoperative pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10).	30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative
Motor block	Motor function was assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs.	30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative

Collaborators and Investigators

• Sponsor: University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
• Investigators: Principal Investigator: Aleksandra Gavrilovska-Brzanov, MD. Msc, Mother Theresa University Clinical Center Skopje Macedonia

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 20, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 3, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: caudal block; hernia repair; local wound infiltration
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: UCTOARICED1